About this trial

The purpose of the study is to verify and validate the parameters collected from mobile devices via the app named "Comestai" and from reference devices. The assessments considered to define comorbidities are included.. Specifically, collection of vital parameters (Blood Pressure, Heart Rate, Respiratory Rate, Oxygen Saturation) through the "Comestai" Application via mobile phones (using photoplethysmographic method) and reference devices such as Withings-Blood Pressure Monitor Connect® (for Blood Pressure), Polar Verity Sense® (for Heart Rate), Masimo-finger sensor® (for Oxygen Saturation, Respiratory Rate), comparing and confirming them. Consent will be sought for the viewing and collection of blood test results that are normally included in evaluations for subjects with overweight and/or obesity and/or diabetes.

Estimated time required for each measurement recording: 10-15 minutes per subject

Total number of subjects: 3000

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Subject must have the ability to understand and provide written informed consent.

Male or Female subject ≥16 and ≤65 of age.

Subject must be willing and able to comply with study procedures.

Disqualifiers

Subject with compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor Region of Interest (ROI) which would limit the ability to test ROI needed for the study.

Subject has a tattoo in the optical path which would limit the ability to test ROI needed for the study.

Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, respiration monitor electrodes or other medical sensors used for measuring vital signs.

Subject with a medical condition which in the opinion of the investigator, does not allow performing the study assessments.

Trial population

Potential adolescent and adult subjects (male and female ≥16 and ≤65 of age), of any race, physiques and skin pigmentation with awide range of health conditions who provided their consent by signing the informed consent form will be screened into the study and provided with a subject specific identification number used throughout the study (i.e. Subject ID).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Data Collection Storage and Processing-Pulse rate

Collect, verify and validate Pulse rate (beats per minute) in data using the Comestai application and reference devices. Pulse rate data obtained using the Comestai application and reference data will be stored on Comestai's secured cloud without any subject identifiable information and will only be recognized using the subject identification number provided during screening. The raw data of subjects' vital signs will be locked, encrypted, and can be read only by Study center team. The measurement method utilized by the app is Remote Photoplethysmography (rPPG). No medical decisions will be made based on the data obtained using the Comestai application, the reference devices, and the pre-scheduled blood sample results.

Time frame